MAUDE Adverse Event Report: LYTRON KODIAK RECIRCULATING CHILLER

Model Number RC045J03BG0C011

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burning Sensation (2146)

Event Date 12/13/2017

Event Type  Injury  

Event Description

Pt c/o burning sensation during mri.Found that the kodiak recirculating chiller was not functioning appropriately.

• Brand Name: KODIAK RECIRCULATING CHILLER
• Type of Device: KODIAK RECIRCULATING CHILLER
• Manufacturer (Section D): LYTRON; woburn MA 01801
• MDR Report Key: 7156888
• MDR Text Key: 96240154
• Report Number: MW5074316
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RC045J03BG0C011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 125